Kornimate/medical-research-clean huggingface dataset:
echocardiography-guided percutaneous patent ductus arteriosus closure

Conditions: Echocardiography; PDA

Summary: since the first successful percutaneous closure under transoesophageal echocardiographic (tee) guidance, many centres explored transcatheter procedures without fluoroscopy. this single centre study aims to show the feasibility and safety of percutaneous patent ductus arteriosus (pda) closure under echocardiography-only guidance during our one-year experience. patients with pda were recruited for percutaneous pda closure guided by either fluoroscopy or echocardiography-only in national cardiovascular center harapan kita. patients were evaluated clinically and radiologically using tte at 6, 24 and 48 hours after the procedure. primary endpoint was the procedural success. secondary endpoints were the procedural time and the rate of adverse events. echocardiography-guided pda closure is non-inferior to fluoroscopy-guided pda closure, with similar procedural times. however, this method is operator-dependent and requires an experienced team for it to be performed successfully.

from march 2019 to april 2020, a total of 60 patients with pda were recruited as participants for this prospective, single-centre, non-randomized clinical trial. they were divided equally into two groups: the fluoroscopy group who underwent percutaneous pda guided by fluoroscopy and the echocardiography group who underwent percutaneous pda closures guided by transthoracic echocardiography (tte) and tee at the national cardiovascular centre harapan kita, jakarta, indonesia. patients with stable hemodynamic and clinically asymptomatic pda were evaluated and considered for transcatheter pda closure. significant chamber enlargement and mild to moderate pulmonary hypertension were also indications for transcatheter closure. ductal morphology was evaluated using multiplanar tte and tee imaging. after the procedures, patients were evaluated and followed-up after 6, 24 and 48 hours to observe any residual shunts and complications. this study protocol conforms to the ethical guidelines of the declaration of helsinki and the nuremberg code with approval from the research ethics committee of national cardiovascular center harapan kita no lb.02.01/vii/475/kep076/2020. written consent to perform the procedure and to use the patients' medical records for this study was obtained from the patients or their parents.

Eligibility criteria:
inclusion criteria: * pda, age \<= 18yo exclusion criteria: * \>= 18yo, eisenmenger syndrome, coexistence of other associated congenital heart disease

Keywords: patent ductus arteriosus (pda) transcatheter closure without fluoroscopy echocardiography
multiple dose study to investigate the safety, tolerability, pharmacokinetics, and efficacy of thdbh120 in chinese patients with t2dm

Conditions: Diabetes Mellitus Type 2

Summary: the aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of thdbh120 injection in participants with t2dm. this study includes three multiple-ascending dose cohorts.


Eligibility criteria:
inclusion criteria: * male or female patients 18 to 75 years of age, inclusive; * have t2dm for at least 6 months before screening based on the disease diagnostic criteria (world health organization \[who\] classification for diabetes); * treated with diet and exercise alone, or a stable dose of metformin (≥1000 mg/day and not more than the locally approved dose) for at least 2 months prior to screening; * have a bmi between 23 and 35 kg/m²(inclusive) at screening; * hba1c levels: 7.0% to 10.0% (inclusive) for subjects treated by diet or exercise alone; 7.0% to 9.0% (inclusive) for subjects receiving stable-dose metformin. exclusion criteria: * have been diagnosed with proliferative diabetic retinopathy, diabetic maculopathy, or non-proliferative diabetic retinopathy requiring treatment during the study; * have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia type 2; * have diagnosed hyperthyroidism or hypothyroidism; * have grade 2 hypoglycemia events or grade 3 hypoglycemia events within 6 months prior to screening; * have a history of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 6 months prior to screening; * presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg; * prolonged qtcf interval on 12-lead ecg at screening (qtcf≥450 ms for males, \>470 ms for females), pr interval \>200 ms, or the presence of long qt syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, wolff-parkinson-white syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia); * weight change ≥ 5% within 3 months prior to screening; * have been treated with insulin, excluding insulin therapy for gestational diabetes mellitus, or acute/temporary insulin therapy (≤ 14 days) for conditions such as acute illness, hospitalization, or elective surgery.
food and nutrition education in quilombolas communities with food insecurity: multi-sector intervention

Conditions: Obesity

Summary: to optimize the food security in quilombolas communities with high prevalence of food insecurity and obesity, the present study proposes to test a multi-sector intervention including agriculture sectors, health professionals and family members of communities, based on promotion of traditional food practices, health eating and enforceability of human right to adequate food.

the present study proposes to develop nutrition education strategies through multi-sector intervention in order to promote the consumption of healthy foods and improvements in the health status of the quilombola population.this is a non-randomized cluster trial in four quilombolas communities in southern brazil (passo do lorenço, algodão, serrinha do cristal and nova palma), combining qualitative and quantitative methodologies.

Eligibility criteria:
inclusion criteria: quilombolas certified communities in rio grande do sul, brazil, with higher prevalence of food insecurity and obesity. exclusion criteria: community leaders with no interest in study intervention.

Keywords: food insecurity
hand & foot nocturnal enuresis tens study

Conditions: Bedwetting

Summary: the investigators believe in order to strengthen the evidence in support of transcutaneous foot stimulation in this population the investigators need to move forward with a randomized comparison study using the tens device on the hand and foot as a control.

nocturnal enuresis is a common problem in children which can have a dramatic psychological and social impact on quality of life. neuromodulation by transcutaneous foot stimulation of peripheral tibial nerve branches has been shown to produce a prolonged inhibition of micturition reflex contractions and significantly increase bladder capacity. the investigators primary goal was to evaluate the effect of foot stimulation on the frequency of nocturnal enuresis episodes in children.

Eligibility criteria:
inclusion criteria: 1. children ages 5 to 18 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis at least 4 episodes per month by history, nocturnal enuresis is a dsm v diagnosable medical condition 2. currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence 3. having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants 4. having been assessed for and treated if applicable for constipation exclusion criteria: 1. children with known neurological disorders which may be contributing to nocturnal enuresis episodes 2. children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants 3. children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat. 4. children who are not adequately potty trained 5. children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence 6. children who do not tolerate initial stimulation training session in the urology clinic upon enrollment 7. children with any implantable medical devices such as a pacemaker will be excluded from the study note: any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.
an open-label, dose escalation study to assess the pharmacokinetics of of asa404 in adult cancer patients with impaired hepatic function

Conditions: Histologically-proven and Radiologically-confirmed Solid Tumors

Summary: this study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of asa404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment. the study will be carried out in cancer volunteer patients (utilizing controls with normal hepatic function) who will be assigned to four hepatic impairment groups according to their pre-dose (day-1) and total bilirubin level. the study will consist of two phases, a (core phase) that will evaluate the pharmacokinetics of a single i.v. dose (900, 1200 and 1800 mg/m2) of asa404 in adult cancer patients with impaired hepatic function, and compared to controls with normal hepatic function. the assessments will be done on the safety and tolerability of that single dose in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function. the extension phase will consist of assessing the safety and tolerability of asa404 at the same three doses in combination with a sponsor-approved taxane-based regimen in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function.


Eligibility criteria:
inclusion criteria: * patients having histologically-proven solid tumors, who are refractory to standard chemotherapy; * patients whom chemotherapy with an investigational agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate; * age ≥ 18 years old * creatinine clearance according to cockcroft-gault formula ≥ 60 ml/min * a minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies; * potassium, calcium, magnesium and phosphorus values within the normal range total bilirubin ≤ 6 x uln exclusion criteria: * patients having cns metastases, must have a ct or mri of the brain performed to rule out cns metastases; * patients with leptomeningeal disease metastases; * major surgery \</ 4 weeks prior to the start of study; * prior exposure to vdas or other vascular targeting agents; * right bundle branch block (rbbb), complete left bundle branch block (lbbb); * administration of cyp1a2 and cyp3a4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug; other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced or metastatic cancer, refractory, core phase, extension phase, dose escalation, standard chemotherapy, pharmacokinetics, doctaxel, paclitaxel, carboplatin, safety, tolerability, hepatic impairment
heart and lung function monitoring system

Conditions: Heart Diseases; Lung Diseases

Summary: the investigator goal is to test a new device to see if it can provide continuous and simultaneous monitoring of heart and lung function.

the purpose of this study is to evaluate and guide progress in the development of a new instrument that may provide continuous, integrated monitoring of heart and lung function.

Eligibility criteria:
inclusion criteria: * adult's ≥ 18 years old exclusion criteria: * wounds, surgical incisions at the site of sensor placement

Keywords: cardiac, respiratory, monitoring
role of amniotic membrane extract eye drops as an adjunctive therapy in resistant corneal ulcers

Conditions: Amniotic Membrane Extract Eye Drops; Resistant Corneal Ulcers

Summary: this study aimed to assess the efficacy of amniotic membrane extract eye drops (ameed) as a supplementary treatment for refractory corneal ulcers.

corneal ulceration is one of the leading causes of corneal blindness. multiple causes of corneal ulceration vary in prevalence from country to country according to geographical and economic conditions. amniotic membrane (am) contains pluripotent stem cells, highly organized collagen, immune-modulators, growth factors, anti-fibrotic and anti-inflammatory cytokines, a variety of matrix proteins, in addition to anti-microbial effect. inspite of the amniotic membrane transplant is still a surgical procedure, it is not indicated in mild to moderate cases of resistant corneal ulceration and persistent epithelial defects and would alter visual function gravely. researchers found that amniotic membrane extract eye drops (ameed) are superior to autologous blood serum in level and variety of growth factors, cytokines, and antimicrobial activity, along with higher success rates and faster healing results; they discarded the amniotic membrane conditioned medium as it failed to provide matching results.

Eligibility criteria:
inclusion criteria: * age from 20 to 80 years. * both sexes. * patients who were suffering from corneal ulcers that showed no signs of improvement after one week of medical intervention. exclusion criteria: * severe corneal melting. * perforated corneal ulcer. * corneal ulcers with significant thinning with or without descemetocele. * patients who were unable to adhere to the treatment plan properly.
spironolactone on fibrosis progrssion-portal hypertension(fp-ph)in cirrhosis

Conditions: Cirrhosis; Portal Hypertension

Summary: the aim of this study is to investigate the effects of spironolactone on liver fibrosis progression and portal pressure gradient in patients with advanced chronic liver disease. eligible cirrhosis patients were 2:1 randomized to either combination (carvedilol and spironolactone) or single (carvedilol) therapy group. changes in virtual portal pressure gradient (vppg) of portal trunk (calculated based on reconstructed 3d model and measured blood flow velocity), liver stiffness measurement (fibroscan) and serum markers of liver fibrogenesis were documented at baseline and six months later.


Eligibility criteria:
inclusion criteria: -proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings exclusion criteria: * treatment with β-blockers or diuretics in the last 3 months * severe cardiopulmonary or renal insufficiency * chronic alcohol abuse * can't tolerate side effects of oral carvedilol or spironolactone * history of variceal bleeding * malignancy * portal vein thrombosis * history of partial splenic embolization or splenectomy * moderate or tense ascites
motor performance in parkinson's disease after high intensive exercise or deep brain stimulation

Conditions: Parkinson's Disease

Summary: the purpose of this study is (1) to provide quantitative information of the motor manifestations of parkinson's disease and (2) to quantify the effect of high intensive antigravity locomotor exercise or deep brain stimulation implantations in parkinson's disease.


Eligibility criteria:
inclusion criteria (exercise arm): * idiopathic parkinson's disease * a stable condition the last 6 months * hoehn and yahr 2 - 3 inclusion criteria (deep brain stimulation arm): * patients referred to deep brain stimulation exclusion criteria: * cardiovascular disease * conditions that contraindicate physical exercise or the examination
a study on the effects of a single dose of prednisone on biomarkers of allergen responses in asthmatics (mk-0000-175)

Conditions: Asthma

Summary: the purpose of this study is to evaluate the relationship between upper and lower airway allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the following: 1) a positive correlation between allergen-induced type 2 t-helper cell (th2) cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation between effects of prednisone versus placebo on th2 cytokines in sputum and nasal exudates.


Eligibility criteria:
inclusion criteria: * has a clinical history of mild to moderate asthma for at least 6 months, but otherwise is in good health * participant with allergic rhinitis and asthma has a history of nonseasonal airway symptoms in response to aeroallergens or has seasonal symptoms but can be evaluated out-of-season * is clinically stable and free of respiratory infection or change in allergen exposure for at least 4 weeks prior to start of study exclusion criteria: * has intolerance to the study drug, inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication * has intolerance to lidocaine/lignocaine, sedatives, atropine or glycopyrrolate, or any other medication associated with bronchoscopy * has taken oral parenteral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 5 weeks of screening and/or during the study * has recent (4 weeks) or ongoing upper or lower respiratory tract infection * has active allergic rhinitis at screening * has received a vaccination within 3 weeks of screening

Keywords: nasal allergen challenge, inhaled allergen challenge, asthma
prevalence of oral lesions in covid-19 patients

Conditions: Oral Lesions; COVID-19; Angiotensin-converting Enzyme 2

Summary: recently, a new coronavirus disease 2019 (covid-19) has appeared and caused an unprecedented pandemic which is considered as an urgent threat to health authorities worldwide. several symptoms are observed which are fever, cough, shortness of breath, headache, runny nose, muscle pain, fatigue, arthralgia, sputum production, conjunctivitis, diarrhea. susceptibility, genetics, systematic diseases, population, gender, and age are crucial considerations for the onset and progression of the viral infection. the patients suffering from asthma or pulmonary deficiency are at high risk of mortality. a metallopeptidase, angiotensin-converting enzyme 2 (ace2) is considered as the functional receptor for sars-cov-2 and it was isolated from a covid-19 patient. ace2 was recognized in type i and type ii alveolar epithelial cells in both nasal and oral mucosa, in the nasopharynx, in the smooth muscle cells and endothelium of vessels in the stomach and the skin, distinctly in the basal cell layer of the epidermis extending to the basal cell layer of hair follicles, and in the basal layer of the non-keratinizing squamous epithelium. in order to study the possible routes of sars-cov-2 infection on the oral mucosa, we investigated whether oral lesions mainly affect the tongue mucosa due to higher ace2-expressing cell composition and proportion more than that in other oral tissues. moreover, appearance of oral lesions were as a result of sars-cov-2 infection or as a side effect of certain drugs for covid-19 treatment was evaluated.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * laboratory-confirmed covid-19 infection (reverse transcription-polymerase chain reaction, rt-pcr). exclusion criteria: * patients without a laboratory-confirmed diagnosis of covid-19 infection. * patients with olfactory or gustatory dysfunctions before the epidemic. * patients with some malignant neoplasms. * patients with neurodegenerative disorders.
genetic variants and oxidative stress as links between periodontitis and metabolic syndrome

Conditions: Periodontitis, Adult; Metabolic Syndrome

Summary: the aim of this study is to investigate the systemic impact of periodontitis in patients with metabolic syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular risk, microbial factors and host genetic variants, and to study the possible effect of mediators of inflammation and oxidative stress as links between the two conditions.

this is a cross-sectional study. 102 patients with metabolic syndrome will be recruited and will have periodontal and dental examination for diagnosis of caries and periodontal diseases. they will undergo blood, saliva, gcf and subgingival plaque sampling and a series of tests on cardiovascular disease, including measures of pulse-wave velocity,carotid intima-media thickness and echocardiography assessment. statistical analysis will assess associations between dental diagnoses and metabolic, cardiovascular, inflammatory, genetic, microbial and cardiovascular risk outcomes.

Eligibility criteria:
inclusion criteria: * caucasian ethnicity * age 18- 75 * diagnosis of metabolic syndrome * presence of at least 12 teeth exclusion criteria: * pregnancy * presence of infectious diseases such as hepatitis and hiv * use of non-steroidal anti-inflammatory drugs (excluding low-dose aspirin) within one month prior to the baseline visit * use of systemic antibiotics within three months prior to the baseline visit * antibiotic pre-medication required for the performance of periodontal examination
the value of multiple urine flow rate measurements in male benign prostatic hyperplasia (bph) subjects

Conditions: Bladder Outlet Obstruction; Lower Urinary Tract Symptoms

Summary: crossover comparison of different flow meters with a digital home flow meter as a reference. main hypothesis: reapeated home flow measurements with a disposable device will provide a better understanding of the patients urinary flow than a single measurement performed in the clinic.


Eligibility criteria:
inclusion criteria: * provision of informed consent * males aged 45-85 years * \>60% of the voiding volume is above 100 ml per voiding verified by a urinary diary * able to read write and understand given instructions exclusion criteria: * patients practicing cic * ongoing symptomatic uti * known neurological disease that is affecting the bladder function * known past or present alcohol or drug abuse * involvement in the planning and conduct of the study (applies to both astra tech staff or staff at the study site) * previous enrolment or randomisation of treatment in the present study. * suspected poor compliance based on less than 80 % compliance to voiding diary * severe non-compliance to protocol as judged by the investigator and/or astra tech * on alpha-blocker or 5-alpha reductase inhibitor treatment, treatment started less than 2 months prior to enrolment * clinic flow below 100 ml

Keywords: lower urinary tract symptoms leading to lower flow rates